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Brief Title: Minimal SN Tumor Burden
Official Title: Minitub: Prospective Registry of Sentinel Node (SN) Positive Melanoma Patients With Minimal SN Tumor Burden Who Undergo Completion Lymph Node Dissection (CLND) or Nodal Observation
Study ID: NCT01942603
Brief Summary: The purpose of this registry is to collect data in order to discover whether melanoma patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND) or not. Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal basin as the SN. However, if the positive (or metastatic) SN is only minimally involved, some centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND procedure does not increase survival for patients with a minimal SN tumor burden, but can add prognostic information, potentially useful in the subsequent decision-making process. However, this is a surgical operation for the patient, which might be accompanied by significant side effects. Moreover, only approximately 20% of patients with a metastatic SN have further lymph node metastases in the same basin, which means that about 4 patients out of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN positive patients could be safely spared from a CLND. It has been demonstrated that breast cancer patients with minimal SN tumor burden can be safely managed with nodal observation only, without performing a CLND. There is evidence that the same situation exists in melanoma as well, but this needs to be validated and this is why we are conducting this registry. The results of this registry will be crucial to establish an accepted standard of care (CLND or nodal observation) for melanoma patients with minimal SN tumor burden.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
U.Z. Leuven - Campus Gasthuisberg, Leuven, , Belgium
CHRU de Lille, Lille, , France
CHU de Nice - Hopital De L'Archet, Nice, , France
Institut Gustave Roussy, Paris, , France
Charite - Universitaetsmedizin Berlin - Campus Mitte, Berlin, , Germany
Universitaetsklinikum - Essen, Essen, , Germany
UniversitaetsMedizin Mannheim, Mannheim, , Germany
Istituto Europeo di Oncologia, Milan, , Italy
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Napoli, , Italy
Istituto Oncologico Veneto IRCCS - Ospedale Busonera, Padova, , Italy
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Erasmus MC Cancer Institute - location Daniel den Hoed, Rotterdam, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw, , Poland
The Institute Of Oncology, Ljubljana, , Slovenia
Hospital Clinic Universitari, Barcelona, , Spain
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
Cambridge University Hospital NHS - Addenbrookes Hospital, Cambridge, , United Kingdom
Guy's and St Thomas' NHS - St Thomas Hospital, London, , United Kingdom
St George's Hospital NHS Trust, London, , United Kingdom
Norfolk And Norwich Hospital, Norwich, , United Kingdom
St Helens & Knowsley NHS Trust - Whiston Hospital, Prescott, , United Kingdom